Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients

Terminated

• Conditions: Liver Transplant; Complications; Liver Failure, Acute

• Registration Number: NCT06263114
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.

Detailed Description

This study is an investigator-initiated, prospective, single-cohort trial to assess the ability of the TruGraf® Liver gene expression panel (GEP) to predict rejection in pediatric liver transplant recipients undergoing surveillance and for-cause liver biopsy.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-16
• Status Verified: 2025-02
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-07
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• All liver transplant patients at least 1 year of age and less than 18 years of age undergoing surveillance or for-cause liver biopsy

Exclusion Criteria

• Non-English, non-Spanish Speaking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy.	Week prior to or at time of biopsy	To evaluate the performance of the blood-based TruGraf® Liver GEP to accurately diagnose rejection, confirmed by surveillance or for-cause liver biopsy.

Secondary Outcome Measures

Name	Time	Method
Utility of the GEP for monitoring liver injury	Week prior to or at time of biopsy	Utility of the GEP for monitoring liver injury (i.e., as treatment is weaned, does the GEP return to a non-rejection correlate).
Comparison of the GEP to non-rejection injury found on biopsy	Week prior to or at time of biopsy	A comparison of the GEP to non-rejection injury (e.g., infection) found on biopsy

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States